Belize, a Central American nation, has joined a small but growing list of jurisdictions where the use of Ivermectin is now authorized or officially allowed for treating SARS-CoV-2, the virus behind COVID-19. Just recently, Acting Director of Health Services for Belize’s Ministry of Health, Dr. Melissa Diaz-Musa explained the situation to local media. What triggered this decision? Well, in the recent interview it apparently is a decision based on what authorities there deem mounting evidence from a series of studies (case series, observational and a handful of actual randomized trials), significantly high safety profile, effectivity and cost. She also pointed to a growing number of established protocols, even ones discussed in America. In what will undoubtedly be deemed a controversial move by key players in research and regulatory power centers in the U.S. and Europe, the move basically represents a sort of pragmatic survival as a Latin American developing nation seeks answers to the pandemic. But TrialSite has monitored a chorus heard from an exponentially growing number of observers supporting the embrace of this drug for research purposes targeting COVID-19 at least. Purportedly taken by over a billion people annually to fight parasites of various types, TrialSite analysts and network picks up growing chatter that a looming shortage of the drug, representing surging demand, could soon be a reality. What is the truth behind Ivermectin and its effectiveness and safety targeting COVID-19? As Operation Warp Speed just allocated another $356 million for yet another novel experimental biological therapy targeting COVID-19 (now over $2.5 billion just for therapies), should there be more attention as well placed on the repurposing of existing approved therapies?
Accumulating Evidence Should Trigger Interest in Research
TrialSite shares the recent interview with Belize’s LoveFm, a local media that secured the interview with the acting health minister. As TrialSite has reported, dozens of studies now reveal a seemingly compelling story: this widely available and economical generic drug appears to obliterate COVID-19. There certainly isn’t sufficient data yet to make any definitive claims but assuredly there is enough evidence justifying NIH, or FDA- supported research.
TrialSite suggests that this data, while certainly not sufficient enough for any medical conclusions, is the result of an accumulation of case series, observational study and a handful of randomized, controlled trials. One prominent observational study in the U.S. was led by a physician/research couple (Dr. Jean-Jacques Rajter and Dr. Juliana Cepelowicz Rajter) and their research team in Broward County. The team found that Ivermectin is associated with lower mortality for those patients infected with SARS-CoV-2. The “ICON” study, now well known among those researchers and journalist following this topic, was accepted into the peer reviewed journal CHEST.
TrialSite has also interviewed and followed the work of Dr. Tarek Alam in Bangladesh; he and team have treated thousands of patients now with Ivermectin and they recently completed a few studies involving the antiparasitic drug, including one published in a peer review journal. These results, which have been called “astounding” by some observers, were summarized in the Trialsite Weekly Round Up.
TrialSite commissioned an objective documentary to investigate what was the reason for the use of the drug in Peru. Other experts are far more cautionary, such as Dr. Carlos Chaccour. The renowned Ivermectin expert represents a consistent voice expressing the potential of the drug but warning all that no scientific conclusions can be made—there just isn’t enough data to justify that.
Physicians from the Front Line COVID-19 Critical Care Alliance (FLCCC) have tracked the Ivermectin research and have established the position that Ivermectin should be embraced by health organizations and agencies (e.g. National Institute of Health, World Health Organization, etc.) for immediate research—the implications are too great not to, the physicians argue. The FLCCC’s Dr. Pierre Kory completed the most comprehensive meta-analysis of Ivermectin studies worldwide that’s available. The physicians held a press conference (TrialSite was the only media to cover live), which led to a presentation at a Senate Hearing with some associated drama from an individual that spoke first and for no apparent reason went on to attack the integrity of the clinicians testimony.
Local Belize media LoveFM took some time with Dr. Melissa Diaz-Musa, acting Acting-Director of Health Services for Belize’s Ministry of Health to discuss the reasons for authorizing the use of Ivermectin by prescription for COVID-19. TrialSite shares excerpts or follow the link to the source.
What is behind the Authorization of Ivermectin for use against COVID-19?
Dr. Melissa Diaz-Musa, Acting Director of Health Services, Ministry of Health and Wellness: “To clarify it’s an anti-parasitic drug. It’s a medication that’s been used safely in humans and animals alike for many years. In the 1980’s Ivermectin actually won the Nobel Peace Prize for its use as an anti-parasitic in developing nations so that speaks a lot about it’s safety profile as well. Over the last few months as you know many countries researchers have been trying to look for medications that can help to reduce viral replication or look for a cure and we do know that this has not been established as yet there is no known cure. But the medical response team along with our Ministry of Health team here we sat down and we revised the research papers, all the articles, everything that we could to look at Ivermectin and its use in other countries and its use in protocols in other countries and we found that it had significant evidence that it has been beneficial in reducing the viral replication – so the multiplication of the virus in your body and some studies have also shown that it has helped with prophylaxis as well. So when we look at the pros and cons with using Ivermectin a decision was made to put it on our protocols for many reasons. It has a significantly high safety profile, it is effective, it is accessible and it is cost effective as well. So when you look at the flip side of not adding it, when you look at a drug like this that you know some protocols in the US and in developing countries have it in place and these protocols the one in the US is a group of critical care physicians who have sent out protocols that are being used all over the world now and they have it in their protocol as a drug to mange COVID. Ivermectin in the research that we have done has shown that it helps to reduce the virus multiplying in your system so once it enters your nasal tract or your mouth or your eyes it gets into your system and in some people it multiplies significantly and in other people it doesn’t. So the mode of action basically it reduces the viral replication so it helps to reduce the severity of the virus. So it’s not a wonder drug, it has shown to help. We do know that countries have had Ivermectin in their protocols like Peru, Brazil and they still do have a high mortality and morbidity in their population but because when we look at the safety profile the cost effectiveness, the data, the evidence that it has on it it’s basically looking at the risks versus benefits and the decision was then made that it would have more benefits.”
LoveFM went on to discuss the issue of self-medication and also private parties buying up the product in bulk. That of course occurred before the approval. Dr. Diaz-Musa shared with the audience that there should be no self-medication and that this drug is only available for COVID-19 via a medical professional prescription.
Dr. Melissa Diaz-Musa, Acting Director of Health Services, Ministry of Health and Wellness: “It’s not licensed for the management of COVID, and it’s not a mandatory treatment so we’ve decided to put it in the protocols because of what has been listed before in addition to the fact that we have moved the medication out of the general public’s hands because people have been calling with wrong doses injecting themselves trying to find a way to prevent themselves from getting COVID and it’s important that we put it back into the hands of the healthcare professionals. So we’ll be able to tell you the appropriate dosage for your weight, we could tell you the appropriate dosage for your age, we know the contraindications, we know the side effects so we would be better able to guide that person with regard to the use of Ivermectin. So I think that’s important. It helps to standardize the care that we’re giving, it’s not only Ivermectin we also give a lot of other medications to help with symptomatic relief, Tylenol, Ibuprofen, Ibuprofen Oral Rehydration salts, vitamin C, vitamin D3 so there are many others areas that we also discuss with patients when treating for COVID. We are not advising that anybody stores it and for that reason that’s another reason why it’s been placed on the protocols. If it’s placed in the protocols the Ministry of Health will procure and have it at our health facilities so that if a patient goes to our health facility we have it there to give that person in the correct dosage with the correct information along with the prescription. So it’s not advisable for you to just go out and purchase bulk. You know human nature is that we will Google things, we will go and look for our own information and because of so much information on the website people felt that they felt compelled to buy it and after discussing all those we decided at the Ministry of Health and Wellness that it’s best for us to standardize its use and ensure that people are using it correctly.”